Electrode insertion tools, lead assemblies, kits and methods for placement of cardiac device electrodes

ABSTRACT

Insertion tools, lead assemblies, kits, and methods for placement of cardiac device electrodes. In some embodiments, an insertion tool having a proximal end and a distal, dissecting end includes a structure configured to receive or engage a structure on a lead assembly. Some embodiments include a lead assembly having an end including a structure configured for engaging the distal end of an associated insertion tool. Some embodiments include kits or systems including both an insertion tool and a lead assembly, each having a structure for engaging the other. In these embodiments, the engaging structures may take several forms including threads, small posts, circular or semi-circular receiving members, and/or a slot. Some embodiments also include methods for placement of cardiac device electrodes with the assistance of an associated insertion tool, wherein the cardiac device electrodes are associated with a lead assembly having an end configured to engage a distal, dissecting portion of an associated insertion tool.

CROSS REFERENCE TO RELATED APPLICATIONS

The present application is related to that of U.S. patent applicationSer. No. 11/006,291, entitled APPARATUS AND METHOD FOR SUBCUTANEOUSELECTRODE INSERTION, published as U.S. Published Patent Application No.2006-0122676 on Jun. 8, 2006, which is incorporated herein by reference.

FIELD

The present invention relates to the field of implantable cardiacstimulus device systems. More specifically, the present inventionrelates to insertion tools, lead assemblies, methods and kits forplacement of cardiac device electrodes.

BACKGROUND

Implantable cardiac stimulus and/or monitoring devices and systems areknown for use in ongoing and prophylactic treatment of cardiacconditions as well as diagnosis of cardiac maladies. Often such systemswill include one or more lead assemblies that carry electrodes that maybe used to sense cardiac activity and/or to deliver therapy to thepatient. Convenient and uncomplicated, as well as quick, implantation ofthe lead assemblies is desirable, and alternatives to existingtechnologies and methods are sought.

SUMMARY

The present invention is, in several embodiments, directed towardinsertion tools, lead assemblies, kits, and methods for placement ofcardiac device electrodes. In some embodiments, an insertion tool havinga proximal end and a distal, dissecting end includes a structureconfigured to receive or engage a structure on a lead assembly. Someembodiments include a lead assembly having an end including a structureconfigured for engaging the distal end of an associated insertion tool.Some embodiments include kits or systems including both an insertiontool and a lead assembly, each having a structure for engaging theother. In these embodiments, the engaging structures may take severalforms including threads, small posts, circular or semi-circularreceiving members, and/or a slot. Some embodiments also include methodsfor placement of cardiac device electrodes with the assistance of anassociated insertion tool, wherein the cardiac device electrodes areassociated with a lead assembly having an end configured to engage adistal, dissecting portion of an associated insertion tool.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of an illustrative electrode insertion toolset;

FIGS. 2A-2E show steps of an illustrative method of implantation of acardiac stimulus device;

FIGS. 3A and 3B are side views of an illustrative electrode insertiontool and an illustrative lead in detached and attached configurations;

FIGS. 4A and 4B are longitudinal cross-sectional views of anotherillustrative electrode insertion tool and an illustrative lead indetached and attached configurations;

FIGS. 4C-4E are views of alternative constructions along lines C-C, D-Dand E-E of the illustrative electrode insertion tool and illustrativelead of FIG. 4A;

FIG. 4F is an illustrative cut-away view along line F-F of FIG. 4C;

FIG. 4G is an illustrative view along line G-G of FIG. 4E;

FIG. 5A is a side view of an illustrative electrode insertion tool andan illustrative lead in a detached configuration;

FIG. 5B is an axial elevation view of the distal end of the illustrativeelectrode insertion tool of FIG. 5A;

FIG. 5C is a side view of the illustrative electrode insertion tool andthe illustrative lead of FIG. 5A in an attached configuration;

FIGS. 6A and 6B are side views of an illustrative electrode insertiontool and an illustrative lead in detached and attached configurations;

FIGS. 7A-7B are cross-sectional views of an illustrative electrodeinsertion tool and an illustrative lead assembly in detached andattached configurations to illustrate a locking mechanism;

FIG. 7C illustrates another locking mechanism;

FIG. 8A is a side view of another illustrative electrode insertion tooland an illustrative lead in a detached configuration;

FIG. 8B is a closer view of the distal tip of the illustrative lead inFIG. 8A; and

FIGS. 8C-8D are perspective views showing detached and attachedconfigurations for the illustrative electrode insertion tool andillustrative lead of FIG. 8A.

DETAILED DESCRIPTION

The following detailed description should be read with reference to thedrawings. The drawings, which are not necessarily to scale, depictillustrative embodiments and are not intended to limit the scope of theinvention.

As used herein, the proximal end of an electrode insertion tool is theend having a handle for grasping by the physician, and the distal end ofan electrode insertion tool is the end having a dissecting tip forforming a path or opening through tissue and/or between layers oftissue. The proximal end of a lead electrode assembly is the end that isconnected to an associated canister, while other end of a lead electrodeassembly is referred to as the distal end.

FIG. 1 is a perspective view of an illustrative electrode insertion toolset. The illustrative set 10 includes several elements, including astraight introducer 12 having a handle 14, a shaft 16, and a distal tip18. A curved introducer 20 is also shown, and includes a handle 22, ashaft 24, and a distal tip 26. A shaping tool 30 is also shown, theshaping tool having posts 32 disposed thereon. The shaping tool 30 maybe used to adjust the curvature or shape of either of the introducers12, 20. The handle of either or both introducers 12, 20 may include aport for fluid infusion, and the shafts 16, 24 or distal tips 18, 26 mayinclude one or more ports allowing fluid (such as a local anesthetic,for example, lidocaine) to be infused during the insertion procedure.The distal tips 18, 26 may be shaped for blunt dissection including, forexample, a relatively sharp distal tip portion forming a generallyconical dissection element. This allows for piercing and/or separationof tissue to form a space for insertion of a lead electrode assembly.

In an illustrative embodiment, a straight electrode insertion tool hasan overall length, including the handle, of about 26.5 cm, with theshaft having an outer diameter of about 3.2 millimeters. Otherembodiments may range from about 1 mm to about 6 mm in outer shaftdiameter, with an overall length between about 10 cm and about 40 cm. Anillustrative shaft is formed of stainless steel, with a polycarbonateproximal handle. Alternatively, a polymer providing added shapeabilitymay be used for the shaft. A polytetrafluoroethylene coating may beused, if desired. Other coatings may be used, including drug elutingcoatings. The overall size may be modified in light of patient anatomy,desired implant location, and the size of the lead electrode assemblybeing used, for example.

FIGS. 2A-2E show steps of an illustrative method of implantation of acardiac stimulus device and lead assembly to a subcutaneous location.Beginning with FIG. 2A, a patient 40 is shown having a heart generallyat 42, with the median or sagittal plane shown generally at 44. At alocation about 0 cm to about 4 cm superior or inferior to the xiphoidprocess 46, a first incision 48 is made at a medial location. In anillustrative embodiment, the first incision 48 is about 1 cm to about 2cm inferior to the xiphoid process. A subcutaneous pocket 50 may beformed in a suitable fashion for receiving the canister of the cardiacstimulus device, with the subcutaneous pocket 50 formed near a secondincision 52. An electrode insertion tool is shown, with shaft 54 andhandle 56, and, as indicated by the arrow, is inserted through the firstincision 48 and advanced toward the second incision 52, creating achannel through the patient's subcutaneous tissue.

Turning to FIG. 2B, the insertion tool is advanced through firstincision 48 toward the second incision 52 through subcutaneous tissueuntil the distal end 58 exits the second incision 52, such that theshaft 54 temporarily resides in the subcutaneous tissue of the patient.Next, a lead assembly 60 is provided, with a distal end 62 and aproximal end 64. The proximal end of the lead assembly 60 is shownincluding a plug or connector for attachment to an associated canister.The distal end 62 of the lead assembly 60 is secured to the distal end58 of the electrode insertion tool. The physician then grasps the handle56 and, as indicated by the arrow, withdraws the electrode insertiontool via the first incision 48, pulling the lead assembly 60 into thesubcutaneous space or channel previously dissected.

Referring now to FIG. 2C, the result of the steps shown in FIG. 2B isthat the lead assembly 60 now resides partly in the patient'ssubcutaneous tissue, with the proximal end with plug or connector 64sitting outside of the patient near the second incision 52, and thedistal end 62 extending out of first incision 48. As indicated in FIG.2C, the next step is for the insertion tool to be inserted through athird incision 70 and advanced toward and through the first incision 48.The third incision 70 may be approximately 8-10 cm (or more or less,depending on patient anatomy) above the first incision 48, to the leftof the median or sagittal plane 44, and cephalad of the first incision48. The first and second incisions may be placed such that a line drawntherebetween is parallel to the patient's sternal midline, with theincisions being spaced about 0 cm to about 5 cm to the left of thesternal midline. In the embodiment shown, a parasternal implant locationis achieved by placing the incisions about 3 cm to the left of thesternal midline. The insertion tool is advanced toward the firstincision 48 until the distal end 58 of the insertion tool exits thefirst incision 48.

Turning to FIG. 2D, the lead assembly 60 is manipulated such that itsdistal end 62 is adjacent the distal end 58 of the insertion tool. Thedistal end 62 of the lead assembly 60 is then secured to the distal end58 of the insertion tool. An implanting physician then grasps the handle56 and withdraws the insertion tool as indicated by the arrow, pullingthe distal end 62 of the lead assembly 60 toward the third incision 70.

FIG. 2E illustrates the completed procedure. The lead assembly 60 isdisposed in a subcutaneous space in a generally “L” shape. The distalend 62 of the lead assembly 60 is disposed near the third incision,which is shown as a closed incision 70′. As shown by the insets, thedistal end 62 of the lead assembly 60 may be secured, using suture hole66, to the fascia near the third incision by sutures 68. Likewise, amedial portion of the lead assembly 60 may be secured to fascia near thefirst incision (shown as closed incision 48′) using suture(s) 86 thatare secured to a suture sleeve 84 that may be secured to the leadassembly 60. The addition of these sutures 68, 86 is optional, but mayaid in acute retention of the position of implantation. As time passes,tissue surrounding the electrode and/or lead assembly will fibrose andalso hold the lead assembly in place. For example, the sutures 68, 86may formed of biocompatible, dissolvable material.

FIG. 2E also illustrates placement of the canister 78 relative to therest of the implanted system. In particular, the canister 78 is placednear the second incision (shown at closed incision 52′) in thesubcutaneous pocket 50 (FIG. 2A). The lead assembly 60 is secured to thecanister 78, and extends first medially toward the first incision (shownas closed incision 48′) and then cephalad toward the third incision(shown at closed incision 70′).

A distal portion of the lead assembly 60 is shown as including aplurality of electrodes, as shown at 80. The number and type ofelectrode(s) may vary, with at least one electrode included. In anillustrative embodiment, the electrodes 80 include a distal ringelectrode used primarily for sensing, a proximal ring electrode alsoused primarily for sensing, and a coil electrode therebetween, with thecoil electrode used for delivering stimulus, although each electrode mayperform more than one function. The canister 78 may also include one ormore electrodes. The lead assembly 60 further includes a proximallyextending shaft having conductors passing therethrough, with the shaftproviding insulation to the conductors, and with the conductor(s)coupled to the one or more electrodes.

Alternatives to the steps shown in FIGS. 2A-2E are available in otherembodiments. In some embodiments, the first incision 48 and/or thirdincision 70 may be at different locations, for example, to the right ofthe median or saggital plane, or, rather than at an anterior position asshown, posterior to the patient. Further, the pocket 50 for receivingthe canister of the system may be moved to a more cephalad position (forexample, near the clavicle). The canister 78 is shown as generallyrectangular, although other shapes, including a long, narrow shape thatconforms to the patient's ribcage, may instead be used.

Part of the implantation procedure shown in FIGS. 2A-2E includes stepsin which an electrode insertion tool is used to first create asubcutaneous pathway, is then connected at its distal end to a leadassembly, and is then used to pull the lead assembly through the justcreated subcutaneous pathway. When the desired configuration has an “L”shape as shown by FIG. 2E, these steps may be performed twice, such thateither one electrode insertion tool is coupled to, de-coupled from,re-coupled to, and re-de-coupled from the lead assembly, or first andsecond electrode insertion tools are successively coupled to anddecoupled from the lead assembly. In either event, it is desired to havethe ability to readily and easily couple the lead assembly to theelectrode insertion tool to perform the step of pulling the leadassembly through the patient's subcutaneous tissue to a desiredlocation. Following are several illustrative examples that provide suchfunctionality.

It may also be noted that the implantation procedure in FIGS. 2A-2E doesnot require the use of a splittable sheath. Additional structures, suchas a sheath or a splittable sheath may be added, if desired, but theprocedure does not require such elements. The method thus includesestablishing a subcutaneous pathway by the use of an implantation tool,securing a lead assembly for use in the cardiac device system to theimplantation tool, and pulling the lead assembly into the subcutaneouspathway, wherein the lead assembly is pulled into the subcutaneouspathway in its finished condition, without the use of a sheath orsplittable sheath thereon.

FIG. 3A is a side view of an illustrative electrode insertion tool 100and an illustrative lead assembly 102 in a detached configuration. FIG.3A generally shows the distal ends of each of the illustrative electrodeinsertion tool 100 and the illustrative lead assembly 102. The electrodeinsertion tool 100 includes a dissecting tip 104, which is shown as agenerally sharp member. Proximal and adjacent to the dissecting tip 104is a lead engaging structure 106 that is configured for engaging thelead assembly 102. Further proximal on the electrode insertion tool 100is a dissecting portion 108 that is shaped to further expand and dissectsubcutaneous space as the electrode insertion tool 100 is advancedthrough subcutaneous tissue.

The lead assembly 102 also includes an engagement structure 110 that isconfigured to engage and secure to the tool 100. In the illustrativeembodiment, the engagement structures 106, 110 take the form ofcooperating threading that allows for rotational fixation of the leadassembly 102 to the introducer 100. The lead assembly 102 defines, atits distal end, a cavity wall 112 shaped to receive the dissecting tip104 therein. As such, the lead assembly 102 includes a receivingstructure including both the engagement structure 110 and thecavity/cavity wall 112. Also shown on the lead assembly 102 is a suturehole 116, which may be used, as illustrated in FIG. 2E, to provide anacute or chronic retention structure.

The electrode insertion tool 100 is shown as including a proximallyfacing shoulder 114. This shoulder 114 may be abrupt, as shown, or maybe smoothed or curved in to avoid catching on and/or tearingsubcutaneous tissue as the electrode insertion tool 100 is manipulatedin a proximal direction. The outer diameter of the dissecting portion108 and/or proximally facing shoulder 114, in some embodiments, may besized to be greater than the outer diameter of the lead assembly 102such that, as the lead assembly 102 is pulled through subcutaneoustissue, drag on the lead assembly 102 is reduced to avoid damage duringthe pulling step. For example, the outer diameter of the dissectingportion 108 may be about 0.3 mm to about 5.0 mm larger than the outerdiameter of a corresponding lead assembly 102 to reduce drag. In otherembodiments, the outer diameter for the electrode insertion tool 100 isgenerally similar to the outer diameter of the lead assembly 102, whichmay reduce the level of patient discomfort during the procedure.

FIG. 3B is a side view of the electrode insertion tool and the lead ofFIG. 3A in an attached configuration. As can be seen at 118, theelectrode insertion tool 100 is secured to the lead assembly 102, withthe cooperative threading of the engaging structures removably fixingthe two pieces 100, 102 together. The cavity wall 112 is formed suchthat the dissecting tip 104 is easily received in the distal end of thelead assembly 102 while the electrode insertion tool 100 is attached tothe lead assembly 102. Once the lead assembly 102 is drawn through asubcutaneous path and the distal end of the lead assembly 102 is at itsdesired location, the suture hole 116 may be used to secure the leadassembly in place. In the illustrative embodiment, the direct attachmentof the lead assembly 102 to the electrode insertion tool 100 allows fora simple and quick implantation procedure.

FIG. 4A is a longitudinal cross-sectional view of another illustrativeelectrode insertion tool 200 and an illustrative lead assembly 202 in adetached configuration. The electrode insertion tool 200 includes adissecting tip 204, an engaging structure 206, and a dissecting portion208. As before, the dissecting tip 204 may be sharp or blunt, and thedissecting portion 208 is sized to further expand a subcutaneous channelformed as the electrode insertion tool 200 is advanced through tissue.

In the embodiment of FIG. 4A, an internal channel 210 is alsoillustrated. The internal channel 210 may be used to infuse a fluidduring the implantation procedure, for example, a local anesthetic,anti-inflammatory drugs, antibiotics, visualization media or any othersuitable material, as desired. The channel 210 is shown with openings atvarious locations, including on the dissecting portion 208 as well asthe more proximal shaft region of the electrode insertion tool 200.These openings may be placed as desired. In addition, an opening may beplaced at or near the dissecting tip 204.

The embodiment of FIG. 4A also illustrates the illustrative leadassembly 202 as including an engaging structure 212, which generallyincludes a ridge 214, and a cavity 216. The cavity 216 and engagingstructure 212 provide a receiving location for a distal portion of theelectrode insertion tool 200 such that the ridge 214 secures the lead tothe tool 200. The lead assembly 202 may also include a suture hole asshown at 218. As indicated by the alternate view lines, FIGS. 4C, 4D and4E illustrate various forms for the engaging structures, and are furtherexplained below. These structures may include select twist-lockingstructures and/or a slide-over or snap-fit structure, as furtherexplained below.

FIG. 4B is a longitudinal cross-sectional view of the electrodeinsertion tool and the illustrative lead of FIG. 4A in an attachedconfiguration. When in the attached configuration, the dissecting tip204 of the electrode insertion tool 200 is disposed in the cavity 216 ofthe lead assembly 202, with the tool engaging structure 212 of the leadassembly coupled to the lead engaging structure 206 of the electrodeinsertion tool 200.

FIGS. 4C-4E are elevation views of constructions along lines C-C, D-Dand E-E of the illustrative electrode insertion tool 200 andillustrative lead assembly 202 of FIG. 4A. Referring to FIG. 4C, theelectrode insertion tool 200 is shown as including the dissecting tip204, lead engaging structure 206, and dissecting portion 208. The leadengaging structure 206 is shown generally at 230 as including a pair oftabs. The lead assembly 202 is shown as including a ridge 214 aboutcavity 216. The ridge 214 is shown generally as a disc that extendsinward from an outer sheath into the chamber 216, the disc including apair of gaps 232 that are spaced and sized to receive the tabs 230 ofthe lead engaging structure 206. Turning to FIG. 4F, it can be seen thatthe disc provides a ledge 234 for holding tabs 230. The tool engagingstructure is shown in FIG. 4F as including a ramp 236 that leads up to aslot 238. When the tabs 230 are passed through the gaps 232 and theelectrode insertion tool 200 is twisted relative to the lead assembly202, at least one of the tabs passes over the ramp 236 until it crossesthe end of the ramp 236 and settles into the slot 238. Maintaining evenslight axial tension can help to hold the tabs 230 in the slot 238 asthe electrode insertion tool is pulled from its proximal end.

Referring now to FIG. 4D, a slide-over or snap-fit structure isillustrated. In particular, the illustrative electrode insertion tool200 includes an engaging structure 206′ including an annular disc 240.The annular disc 240 projects out from the surface of the engagingstructure, but with a lesser diameter than the outer diameter of thedissecting portion 208. The lead assembly 202 includes a chamber 216 anda ridge 214′ which is also a disc 242 structure, this time projectinginward from the outer wall of the chamber 216. One, the other, or bothof the discs 240, 242 may be flexible to allow the discs to be passedover one another.

Referring now to FIG. 4E, another construction is shown, this time withthe electrode insertion tool 200 including an engagement structure 206″having a disc defining gaps 250. Again, the engagement structure 206″sits proximal of the dissecting tip 204 and distal of the dissectingportion 208. The lead assembly 202 includes a ridge 214″ and a chamber216, with the ridge 214″ reduced to tabs 252 sized to fit through thegaps 250 of the electrode insertion tool 200. FIG. 4G shows thestructure of the electrode insertion tool from line G-G. As can be seen,the engaging structure 206″ on the electrode insertion tool 200 againincludes the gap 250 and defines a channel for sliding the tabs 252 up aramp 254 to a receiving slot 256. Again, a certain amount of axialtension may help to retain the tab(s) 252 in the slot 256.

In FIGS. 4C and 4E, the number and shape of the tabs 230, 252 may vary,and the particulars described in each structure are merely illustrativeof some embodiments.

FIG. 5A is a side view of an illustrative electrode insertion tool 300and an illustrative lead assembly 302 in a detached configuration. Theelectrode insertion tool 300 again includes a dissecting tip 304, anengaging structure 306, and a dissecting portion 308 which may beincluded to further dissect tissue. The engaging structure includes aslot 310 that is adapted to receive a corresponding engaging structure320 on the lead assembly 302. Openings 312 are also shown andcommunicate with the slot 310, allowing a suture to pass therethrough.

The lead assembly 302 includes, as indicated, an engaging structure 320,which is shown as including a suture hole. The lead assembly 302, aswith each lead assembly shown herein, may include any suitable number,configuration, and type of electrodes. One suitable configuration isshown in FIG. 5A as including a distal ring electrode 322 and a proximalring electrode 326, with a coil electrode 324 therebetween. Otherconfigurations may also be used, as suits the particular system,application, and patient. The lead assembly 302 includes an engagingstructure 320 that extends therefrom. As explained below by reference toFIG. 5C, the engaging structure 320 of the lead assembly 302 is sizedand shaped for placement in the slot 310 of the electrode insertion tool300. Also, the engaging structure 320 of the lead assembly 302 is shownwith a suture hole that may be used both in securing the lead assemblyto the electrode insertion tool, and also for suturing to tissue afterplacement.

FIG. 5B is an axial elevation view of the distal end of the illustrativeelectrode insertion tool of FIG. 5A. The electrode insertion tool 300includes the dissecting tip 304 and the engaging structure 306. Thedissecting portion 308 is omitted, as it may be omitted in someembodiments not only of the electrode insertion tool 300 in FIGS. 5A-5C,but also in the other embodiments shown herein. The engaging structure306 includes slot 310 and openings 312 that communicate with the slot310.

FIG. 5C is a side view of the illustrative electrode insertion tool andthe illustrative lead of FIG. 5A in an attached configuration. As can beseen, the engaging structure 320 of the lead assembly 302 is insertedinto the slot 310. A suture 330 passes through the openings 312 to thesuture hole on the engaging structure 320 of the lead assembly 302 whileit rests in the slot 310. As such, the suture 330 secures the leadassembly 302 to the electrode insertion tool 300. If desired, theengaging structure 320 of the lead assembly 302 may be shaped or markedto aid in correct alignment of the suture hole of the engaging structure320 with the openings 312 and the slot 310. For example, the engagingstructure 320 of the lead assembly may be oblong or polygonal.

In the embodiment of FIGS. 5A-5C, the electrode insertion tool 300includes a receiving portion for receiving the engaging structure 320 ofthe lead assembly 302. The receiving portion includes the engagingstructure 306 at the distal end of the electrode insertion tool.

FIG. 6A is a side view of an illustrative electrode insertion tool 400and an illustrative lead assembly 402 in a detached configuration. Theelectrode insertion tool 400 includes a dissecting tip 404, an engagingstructure 406 and a dissecting portion 416. The example lead assembly402 includes an engaging structure 420 including a suture hole 422, aswell as a configuration of multiple electrodes 424, 426, 428.

The illustrative engaging structure 406 includes a hook 408, elongateshaft 410, and actuator 412, with the actuator 412 shown as beingassociated with the device handle 414. The hook 408 is shown in aretracted position such that its distal end exits and then reenters thelead assembly 402. The actuator 412 is coupled to the elongate shaft 410to control whether the hook 408 is in the retracted position shown inFIG. 6A or the extended position shown in FIG. 6B.

FIG. 6B is a side view of the illustrative electrode insertion tool andthe illustrative lead of FIG. 6A in an attached configuration. Theactuator 412 on the device handle 414 has been manipulated, such thatthe hook 408 extends from the distal end of the electrode insertion tool400 and away from the reentry opening 418. The hook 408 has been placedinto the suture hole 422 on the engaging structure 420 of the leadassembly 402. Thus, the engaging structure 406 of the electrodeinsertion tool 400 interacts with the engaging structure 420 of the leadassembly 402 to secure the two together. In some embodiments, a slot maybe provided on the electrode insertion tool 400 to receive the engagingstructure 420 of the lead assembly as well, for example, in a manner asshown in FIGS. 5A-5C.

FIGS. 7A-7C show an illustrative embodiment in which a locking structureis provided in addition to the engaging structures. Referring to FIG.7A, an electrode insertion tool 500 is shown detached from anillustrative lead assembly 502. The electrode insertion tool 500includes a dissecting tip 504, and engaging structure 506 (shown asthreading), and a dissecting portion 508. A locking structure 510 isalso shown.

The lead assembly 502 includes an engaging structure 512 for threadingonto the engaging structure 506 of the electrode insertion tool 500. Thereceiving chamber 514 is configured to receive the distal end of theelectrode insertion tool 500. A locking structure 516 is also shown, andis further explained by reference to FIG. 7B.

Referring to FIG. 7B, the engaging structures 506, 512 of the electrodeinsertion tool 500 and lead assembly 502 are shown in a securedconfiguration. The locking structure 510 of the electrode insertion tool500 is shown as including a locking key 520. When advanced as shown, thelocking key 520 engages the locking structure 516 of the lead assembly502, preventing the lead assembly 502 from becoming unthreaded from theelectrode insertion tool 500.

FIG. 7C shows another embodiment, including the actuator 542 for thelocking key 520. In particular, the actuator 542 may be part of thedevice handle 540. The locking key 520 may be coupled to the actuator542 by an elongate shaft extending through the length of the electrodeinsertion tool 500. The embodiment of FIG. 7C shows an alternative tothe locking structure 516 of FIGS. 7A-7B. In particular, rather than asmall location that may receive the locking key 520, the lead assembly502′ may include a fin 532 that prevents full rotation of the leadassembly 502′ relative to the electrode insertion tool 500 when thelocking key 520 is disposed in the receiving chamber 530. Several fins532 may be provided, or a solid member may be provided to take up aportion of the space in the receiving chamber 530 to prevent rotation ofthe lead assembly 502′ relative to the electrode insertion tool 500.

FIGS. 7A-7C also illustrate an electrode insertion tool 500 whichincludes a distal enlargement for dissecting patient tissue that has adistally facing dissecting portion 508 as well as a proximally facing,non-abrupt shoulder 550. As discussed above, the proximally facingshoulder 550 may be formed to allow smooth passage through the alreadydissected subcutaneous tissue, while also creating a pathway for drawingthe lead assembly 502, 502′ easily therethrough. A smooth shoulder maybe provided in any suitable fashion, for example, by smoothing the outeredge of the shoulder down, or by providing an angled shoulder, as isshown in FIGS. 7A-7C.

FIG. 8A is a side view of another illustrative electrode insertion tool600 and an illustrative lead assembly 602 in a detached configuration.The electrode insertion tool 600 includes a receiving portion 604located proximal of a dissecting tip, with an additional dissectingportion extending proximally of the receiving portion 604. The receivingportion 604 includes a channel 606 and a slot 608, with the channel 606and the slot 608 shown in phantom to illustrate that they are not opento the outer surface of the electrode insertion tool 600. Theillustrative lead assembly 602 includes electrodes 610 and an attachmentstructure 612 including a tab 614.

FIG. 8B is a closer view of the distal tip of the illustrative lead inFIG. 8A. The attachment structure 612 extends axially from the distalend of the lead assembly 602 (FIG. 8A). A tab 614 extends laterally fromthe distal end of the attachment structure 612. The attachment structure612 and tab 614 are configured to cooperate with the receiving portion604, channel 606 and slot 608 shown in FIG. 8A, as is further shown inFIGS. 8C-8D.

FIGS. 8C-8D are perspective views showing detached and attachedconfigurations for the illustrative electrode insertion tool andillustrative lead of FIG. 8A. The attachment structure 612 is alignedsuch that the tab 614 aligns with the receiving portion 604. Asindicated by arrow 630, the attachment structure 612 is inserted in thereceiving portion 604 until the tab 614 is inside the receiving portionand aligns with the channel 606. As indicated by line 632, theattachment structure 612 and lead assembly are then rotated relative tothe insertion tool 600 (or vice versa), such that the tab 614 slidesthrough the channel 632.

In the illustrative embodiment of FIGS. 8A-8D, the slot 608 is included.The slot 608 is optional, and may be omitted if desired. As indicated byline 634, once the tab 614 slides through the channel 606 to a positionin alignment with the slot 608, the lead assembly and insertion tool 600are moved axially relative to one another such that the tab 614 entersthe (optional) slot 608.

FIG. 8D shows the lead assembly secured to the insertion tool 600, withthe attachment structure 812 engaged with the slot 608 after passing thetab 614 through the receiving portion 604 and channel 606. While in thisconfiguration, the insertion tool 600 is drawn out through thesubcutaneous path it established prior to being connected to the leadassembly. Once the insertion tool 600 has been withdrawn, the engagingstructure 612 is disengaged by maneuvering the tab 614 out of the slot608, into the channel 606, and around to the receiving structure 604.

Those skilled in the art will recognize that the present invention maybe manifested in a variety of forms other than the specific embodimentsdescribed and contemplated herein. Accordingly, departures in form anddetail may be made without departing from the scope and spirit of thepresent invention as described in the appended claims.

1. A tool for use in subcutaneous insertion of a lead electrodeassembly, the tool comprising: a proximal end having a handle; a distalend including a dissecting tip shaped for separating subcutaneous tissueto form a channel therethrough, and an engaging structure disposedadjacent to the dissecting tip; and a shaft extending between theproximal and distal ends; wherein the engaging structure is configuredto directly engage a portion of an associated lead assembly.
 2. The toolof claim 1, wherein the distal end further comprises a dissectingportion proximal to the engaging structure, the dissecting portionshaped to further separate subcutaneous tissue relative to thedissecting tip such that, when the engaging structure is used to securethe lead electrode assembly thereto, and the handle is pulled in aproximal direction, the dissecting portion reduces drag on the leadassembly.
 3. The tool of claim 1, wherein the distal end furthercomprises a dissecting portion proximal to the engaging structure, thedissecting portion shaped to further separate subcutaneous tissuerelative to the dissecting tip.
 4. The tool of claim 3, wherein thedissecting tip, engaging structure, and dissecting portion generallyform a conical portion with a discontinuity at the engaging structure,the discontinuity extending at least partly about the conical portion.5. The tool of claim 4, wherein the discontinuity extends wholly aroundthe conical portion.
 6. The tool of claim 5, wherein the engagingstructure includes a threaded portion.
 7. The tool of claim 5, whereinthe engaging structure includes a transversely extending structure. 8.The tool of claim 7, wherein the transversely extending structure formsa ridge and a slot.
 9. The tool of claim 5, wherein the engagingstructure includes a circular protrusion having axial flexibility. 10.The tool of claim 5, wherein the engaging structure includes a circularprotrusion having at least one slot extending therethrough.
 11. The toolof claim 1, further comprising means for locking the tool in an engagedconfiguration relative to a lead assembly having an engaging structureconfigured to engage the engaging structure of the tool.
 12. The tool ofclaim 1, further comprising a locking member coupled to a controlmechanism disposed relative to the handle, the locking member configuredto lock the tool in an engaged position in response to actuation by thecontrol mechanism.
 13. The tool of claim 1, further comprising a lockingmember coupled to means for controlling the locking member, the meansfor controlling the locking member accessible at or near the handle, thelocking member configured to lock the tool in an engaged configurationrelative to a lead assembly when actuated by the means for controlling.14. The tool of claim 1, wherein a shoulder is defined between thedistal end and the shaft proximally adjacent the distal end, wherein theshoulder is shaped for non-traumatic passage in a proximal directionthrough subcutaneous tissue.
 15. A tool for use in subcutaneousinsertion of a lead electrode assembly, the tool comprising: a proximalend having a handle; a distal end having a coupling structure; and ashaft extending between the proximal and distal ends; wherein: thecoupling structure includes a wire member having an engaging section;the shaft includes an actuating member coupled to the wire member of thecoupling structure; and the handle includes a control structure coupledto the actuating member, the control structure configured for a firstposition in which the actuating member is withdrawn into the engagingstructure and a second position in which the actuating member extendsfrom the engaging structure to engage a corresponding structure of thelead electrode assembly.
 16. A system for providing an implanted cardiacstimulus device, the system comprising: an introducer tool having ahandle, a dissecting end, and a shaft therebetween, the dissecting endincluding a dissecting tip and an engaging structure disposed proximallyadjacent to the dissecting tip; a cardiac electrode lead having at leastone of a sensing electrode and/or a stimulus electrode disposed thereon,the lead comprising a first end having a receiving structure configuredto receive the dissecting tip therein and engage the engaging structure.17. The system of claim 16, wherein the receiving structure and theengaging structure are configured for twisting engagement thereof. 18.The system of claim 16, wherein the receiving structure and the engagingstructure are configured for snap-fit engagement thereof.
 19. The systemof claim 16, wherein the introducer tool further comprises means forlocking the introducer tool and the cardiac electrode lead in an engagedstate.
 20. A system for providing an implanted cardiac stimulus device,the system comprising: an introducer tool having a handle, a dissectingend, and a shaft therebetween, the dissecting end including a dissectingtip and a receiving structure disposed proximally adjacent to thedissecting tip; a cardiac electrode lead having at least one of asensing electrode and/or a stimulus electrode disposed thereon, the leadcomprising a first end having an engaging structure extending therefrom,the engaging structure configured to be received by the receivingstructure.
 21. The system of claim 20, wherein the engaging structureand the receiving structure include suture locations configured suchthat, when the engaging structure is received by the receivingstructure, a suture may be added thereto for securing the engagingstructure to the receiving structure.
 22. A method of implanting a leadassembly for a cardiac stimulus system, the method comprising: creatinga first incision and a second incision; providing an introducer toolhaving a proximal end with a handle and a distal end having a dissectingtip and a lead engagement structure for engaging an associated leadassembly; advancing the introducer tool into the first incision towardthe second incision such that the dissecting tip dissects subcutaneoustissue and the lead engagement structure is exposed to subcutaneoustissue and fluids; exposing at least the lead engagement structure atthe second incision; providing a lead assembly having at least a distalend with a tool engagement structure configured to engage the leadengagement structure; securing the distal end of the lead assembly tothe distal end of the introducer tool by twisting engagement of the leadengagement structure to the tool engagement structure; and pulling theintroducer tool handle to draw a portion of the lead assembly into thesubcutaneous tissue between the first and second incisions.
 23. Themethod of claim 22, wherein the first incision is at a medial locationand the second incision is at a lateral location.
 24. The method ofclaim 23, wherein the first incision is at about the level of thexiphoid process.
 25. The method of claim 22, further comprising:withdrawing the introducer tool via the first incision to draw a distalportion of the lead assembly out of the first incision, leaving aproximal portion of the lead assembly in the subcutaneous tissue betweenthe first and second incisions; creating a third incision; advancing theintroducer tool into the third incision toward the first incision suchthat the dissecting tip dissects subcutaneous tissue and the leadengagement structure is exposed to subcutaneous tissue and fluids;exposing at least the lead engagement structure at the first incision;securing the distal end of the lead assembly to the distal end of theintroducer tool by twisting engagement of the lead engagement structureto the tool engagement structure; and pulling the introducer tool handleto draw a portion of the lead assembly into the subcutaneous tissuebetween the first and third incisions.
 26. The method of claim 25,wherein the third incision is located cephalad of the first incision.27. The method of claim 22, wherein the introducer tool includes alocking mechanism and the method further comprises engaging the lockingmechanism to keep the introducer tool and the lead assembly secured attheir distal ends.
 28. A lead assembly for a cardiac stimulus system,the lead assembly comprising: a distal end comprising at least a firstelectrode and a distal tip; and a proximally extending shaft includingan electrical conductor coupled to the first electrode; wherein thedistal end further comprises an engagement structure configured fordirect engagement with an associated introducer tool and a receivingportion for receiving the distal end of the associated introducer toolsuch that, when an associated introducer tool is received in thereceiving portion, the distal tip of the lead assembly extends over andaround a portion of the associated introducer tool.
 29. The leadassembly of claim 28, wherein the engagement structure includes threads.30. The lead assembly of claim 28, wherein the engagement structureincludes one or more tabs extending into the receiving portion from anouter sheath near the distal tip.
 31. The lead assembly of claim 28,wherein the engagement structure includes one or more slots adjacent adisk, the slots sized and configured to receive corresponding tabs onthe associated introducer tool.
 32. A method of implanting a cardiacdevice system comprising: establishing a subcutaneous pathway by the useof an implantation tool; securing a lead assembly for use in the cardiacdevice system to the implantation tool; and pulling the lead assemblyinto the subcutaneous pathway, wherein the lead assembly is pulled intothe subcutaneous pathway in its finished condition, without the use of asheath or splittable sheath thereon.